SVED® Wound Treatment System User Manual
Contents
1. During intermittent operation the SVED will provide target therapy pressure throughout the on part of the cycle and approximately 25 mmHg throughout the off part of the cycle By maintaining this lower pressure while the unit is off the dressing seal is never compromised This method of applying intermittent pressure also increases patient comfort SVED System User s Manual 14 Wound Care Anywhere Battery Operation NOTE The SVED Wound Treatment System is designed to permit use of the product while the internal battery is charging The therapy unit will continue to operate properly while charging is taking place Average Battery Life The specified battery life of the SVED Wound Treatment Unit with a fully charged battery is approximately 12 hours The actual life is dependant on the integrity of the dressing A leak in the dressing can reduce overall battery longevity significantly Average Time for Recharging To ensure the battery has been fully charged the unit should be connected to an A C supply for approximately 3 hours After approximately 2 hours of charging the unit will have achieved 8096 of total battery capacity Low Battery Alarm While running on battery a low battery alarm will chirp every 10 seconds and the OFF button will begin flashing when remaining capacity of the battery is less than 2096 Typically the unit will continue to operate for approximately 1 hour after the low battery alarm is activ2. Wound Care Anywhere SVED simplicity results SVED Wound Treatment System User Manual Wound Care Anywhere CAUTION This SVED Wound Treatment System User s Manual is not a guarantee or warranty It is intended only as an operational guide For additional information and questions please contact Innovative Therapies Inc s ITI Customer Service department at 1 866 ITI NPWT 484 6798 e In order for the SVED Wound Treatment System to provide safe reliable and proper performance the following conditions must be met Failure to comply with these conditions will void all pertinent warranties Allassembly operation adjustment modification maintenance and or repair must be carried out only by qualified personnel authorized by ITI The electrical installation of the room in which the device will be used must comply with applicable wiring standards and electrical codes The product must be used in accordance with this manual and all associated labeling and the Instructions for Use Notice to Users CAUTION Federal law restricts this device to sale by or on the order of a physician As with any prescrip tion medical device failure to follow product instructions or changing settings and performing therapy applications with out the express direction and or supervision of a trained clinical caregiver may lead to improper product performance and the potential for serious or fatal injury Wound Care Anywhere
3. CICERO UR o 47 9500 SPO CU COMME CE eere ers eese E rr E E E eee EE E eer serere sa eso Eee ves b eR esses E E sedie eee read 47 2000 SVAMP Y CorinleCLOT eise Eee tI ete ere eaae LER ERE Ne PR OD et OUI NO sander es On i tee I e e este e DN EVE 47 2500 Polyurethane Drape 10 per PKS 3 corno or RES cacevesonauseessecgeceussecoevsscsaseanesedavadeeessezesbansassdaveceneas 47 7000 NOTE Part numbers for Canisters Dressings and Disposable Accessories may be obtained by visiting ITI s website www ITIMEDICAL com NOTE In order to assure the highest safety quality and efficacy of the products the SVED Wound Treatment System should only be used with Innovative Therapies Inc s disposables and ITI Dressings should only be used with the SVED Wound Treatment System SVED System User s Manual 20 7 Questions amp Information For additional information pertaining to the SVED Wound Treatment System please contact your local ITI representative or Call our customer support professionals at 1 866 484 6798 3770 Park Central Boulevard North Pompano Beach Florida 33064 www itimedical com customerservice itimedical com For questions or comments regarding the content of this User s Manual please contact Innovative Therapies Inc ITI at the above address Please contact ITI Customer Service at 1 866 484 6798 for issues concerning the product and its use Duoderm is a trad
4. Adapter should be inspected regularly for damage and or unusual wear Replace damaged or worn Power Supplies immediately A C Adapters are available from ITI WARNING The SVED Wound Treatment Unit should only be used with the supplied A C Adapter Use of an incorrectly rated adapter could create a shock hazard for the patient or caregiver WARNING Avoid spilling liquid on any part of the therapy unit Liquids can cause corrosion when left on electronic con trols which can lead to failure Component failure may cause the therapy unit to operate erratically possibly causing a potential hazard to the patient or Caregiver WARNING Particular care must be taken when handling undiluted germicide concentrate or chlorine bleach including proper shielding of eyes Always mix by adding concentrated germicide or chlorine bleach to the water NEVER intermix germicides or mix germicides with chlorine bleach SVED System User s Manual 6 Wound Care Anywhere 3 Patient Care It is recommended that all sections of this manual be reviewed prior to using the product Carefully read the INDICATIONS CONTRAINDICATIONS PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting to perform patient care for a patient with the SVED Wound Treatment System Applying the Dressing 1 Cleanse wound according to institution protocols or physician order 2 Debride all necrotic tissue including eschar and hardened slough 3 Becertain the wound h
5. Automated alarms for leak low pressure and full canister Alarms provide both a visual and audible indi cation Alarms will self reset once a problem is corrected or can be manually reset by turning the therapy unit OFF and ON SafetyGuard A unique non Luer Lock connector is provided for irrigation therapy that will not permit an accidental connection to a patient s IV line IV Pole Bed Hanger Adapter Pole clamp permits the unit to be mounted to a wide range of standard IV poles 0 9 to 2 2 2 to 5 0 cm in diameter Stowable bed hangers permit the unit to be hung from a wide range of hospital bed foot boards SpeedConnect Six foot dual lumen tubing set with adhesive flanges to permit easy connection to dressing Single Patient Use Canister 300cc canister for irrigation and normally exudating wounds CAUTION Use of Large Canisters 500ml may increase serious risks associated with excessive fluid loss Monitor patient status continually DO NOT USE for infants or other patients with low fluid volume nor for patients at high risk of major hemorrhage Light Weight The therapy unit weighs only 1 9 Lbs 862 g and can be easily carried and transported Long life Pump Diaphragm type pump with brushless motor increases life expectancy of the unit and minimizes maintenance requirement SVED System User s Manual 4 Wound Care Anywhere 2 Care amp Cleaning Introduction The following instructions are the Innovative Therap
6. in a 24 hour period DRESSING CHANGES Clean the wound per physician order prior to dressing application Routine dressing changes should occur every 48 to 72 hours Dressing changes for infected wounds should be accomplished more frequently then 48 72 hours Always replace with sterile disposables from unopened packages Follow established institution protocols regarding clean versus sterile technique MONITORING THE WOUND Inspect the dressing frequently to ensure that the foam is collapsed and that therapy is being delivered in a consistent manner Monitor periwound tissue and exudate for signs of infection or other complications Extra care and attention should be given if there are any signs of possible infection or related complications Infection can be serious With or without the SVED Wound Treatment System infection can lead to many adverse complications including pain discomfort fever gangrene toxic shock septic shock and various other complications With signs of more serious complications of infection discontinue use of the SVED Wound Treatment System until the serious infection is diagnosed and properly treated DISCOMFORT ADHERENCE If patient complains of discomfort during dressing change consider pre medication use of a non adherent prior to foam placement or irrigation of a topical anesthetic agent such as 196 Lidocaine prior to dressing removal UNSTABLE STRUCTURES Over unstable body structures such as unstable c
7. or necrotic tissue with eschar present Do not place the Svamp Dressing over exposed blood vessels or organs The Svamp Dressings are also contraindicated for hydrogen peroxide and solutions which are alcohol based or contain alcohol It is not recommended to deliver fluids to the thoracic cavity Precautions Precautions should be taken for patients with active bleeding difficult wound hemostasis or who are on anticoagulants When placing the Svamp Dressing in close proximity to blood vessels or organs take care to ensure that they are adequately protected with overlying fascia tissue or other protective barriers Exposed tendon nerves or blood vessels should be protected by moving available muscle or fascia over them or by a layer of synthetic material Greater care should be taken with respect to weakened irradiated or sutured blood vessels or organs Bone fragments or sharp edges could puncture a dressing barrier vessel or organ Wounds with enteric fistula require special precautions in order to optimize therapy Additional Precautions Defibrillation Remove the Svamp Dressing if defibrillation is required in the area of dressing placement Failure to remove the dressing may inhibit electrical current transmission and or patient resuscitation Magnetic Resonance Imaging MRI The SVED Wound Treatment Unit is not MRI compatible Do not take into the MRI area e Large Canisters Use of Large Canisters 500ml may increase serious r
8. ED Wound Treatment Unit The section explains the procedure for activating therapy and explains the major functions that are adjusted from the control panel Carefully read the PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting to operate and adjust the SVED Wound Treatment Unit WARNING The SVED Wound Treatment Unit should only be used with the supplied A C Adapter Use of an incorrectly rated adapter could create a shock hazard for the patient or caregiver The part number for the adapter can be found in the REPLACEMENT PARTS section of this manual Power On Off The ON and OFF buttons are located on the front top of the control panel The ON and OFF buttons control the application of power to the therapy unit ON 1 OFF 0 Canister Full Low Pressure Leak 70 mmHg 125mmHg 150mmHg SVED System User s Manual 12 Wound Care Anywhere Power Up Procedure i Verify the dressing application is correct the tubing is connected the Dressing Suction Tube clamp is open and the Dressing Irrigation Tube clamp is closed 2 Place the therapy unit in an upright position as level with the wound as possible The device can be placed on a table hung from a footboard or attached to an IV pole using the I V Pole Bed Hanger adapter CAUTION The LV pole clamp should only be used on poles that are in excess of 0 9 2 2 cm diameter and are securely attached to a bed frame or suitable stand To ensure stabi
9. Table of Contents Te EPOCH ON deae cosuci E A asa opu E T 2E VMRA N d seva buds 1 PC CAT ONS caeiuseesadiaocide ve eee be ebore pu ao Qo aei SES EE PovwsR cuz EsEsba dada da Reis 1 Contraindicati nS NET DOS 1 Precautions cciieddscnsiasvanctiesundecadesceuasacasaescacdcnduasetessaccadudecsepasepeccsanncee 1 Additional Precautions ccncucectccascsasatasccvcceedlatecntese cuwidadenantadasaeadacedte 1 Safety TIPS RN eserse neea T 2 FBSUII BS 1 ueiuesespesisat o sive Neve aei sevi psseadeeteyDasvcecs erea SPINA EPIS IE 4 s Car amp Cleaning oosssvsxaoreReys qvx ur nive seriei st stosstss rs NT RID ivi MUSEI KE 5 Mit EOGHCDIGI s aec eerta todos dowene rus LUE evoiwbx c eimvv aM t n r SUPR VE ERE I MEE EiS 5 Protective EQUI SIGN ii cswssssncnwncavioncsancaccaneawssunceaactdesiaanivenetucteuenssant 5 DVIS a10 Stl feet T M 5 Daily Care and Cleaning saciauwsasiisihishiereintaesasssasserennaisiannns 6 Weekly Care and Cleaning xus sese aen b enia du ee Y Pen Pre DExIDAMI x x VIV ada i udwexe 6 PP UE EI MN TET NU EN RHET 7 Applying the Dressing cerei ddi sapo Peta Enea Ea EE DEG Laer In added i eee 7 Canisrer InstellabfOll svessionien niens rnEeE aie OR PIE DRE UE 9 Canister Removal oes ees eben c pub bo dubuva tud itai sed Eeka P tdt india da 10 Dressing REMOVAL 5525 te iar even Pen 0h nsn tastit YN VEL YE E Re T Sa ea EEE 10 Disposal of Dressings and Canister esee 11 4 Operating Ist cbl OflS 3 usees
10. as achieved hemostasis 4 Visually examine and palpate wound bed to locate any blood vessels or delicate underlying structure in close proximity 5 Irrigate wound with normal saline or solution per physician order 6 Prepare area around wound to permit adhesion of the polyurethane drape NOTE If peri wound area is excessively moist or oily a medical grade liquid adhesive may improve sealing For fragile skin use a skin sealant prior to drape application or frame the wound with a skin barrier layer such as Duoderm Cut the drape to a size large enough to go over the foam and the barrier layer only 7 Take measurements of the wound dimensions and note pathology Cut the Svamp Dressing to a size that is appropriate for the wound NOTE Do not trim the dressing over or around the wound site to help prevent debris from the dressing from falling into the wound 8 Place the Svamp Dressing in the wound site taking care to avoid contact with the peri wound tissue WARNING Do not packthe Svamp Dressings into any areas of the wound Forcing dressings in a compressed manner into any wound is contrary to approved protocols NOTE The Svamp should cover the entire wound margin including tunneling and undermining However the Svamp should not be in contact with intact skin SVED System User s Manual 7 Wound Care Anywhere 9 Size and trim the Polyurethane Drape to cover dressing plus a 3 5 cm border of intact skin Save the extra d
11. ated Low Battery Shutoff If the battery charge falls below a critical level the unit will shutoff automatically and therapy will be discontinued At this point the unit must be plugged into an A C power source for therapy to resume Once the A C Adapter is plugged in pressing the ON button will restart the unit Recharging the Battery Plug the power cord from the A C Adapter into the power receptacle on the side of the therapy unit Plug the A C Adapter into a suitable 120 VAC 60 Hz wall outlet When the unit is connected to an AC power source the GREEN LED below the power receptacle will illuminate indicating AC power is present and the AMBER LED will illuminate when the battery is charging Once the battery is fully charged the AMBER LED will extinguish indicating the charge cycle is complete When the SVED Wound Treatment Unit is disconnected from the AC power source the device will automatically switch over to the internal battery and continue to operate without interruption SVED System User s Manual 15 Alarm Operation Clearing an Alarm Condition Wound Care Anywhere To clear an alarm condition turn the therapy unit OFF then ON The alarm will clear when the power is cycled Alarm Troubleshooting CANISTER IS FULL LOW PRESSURE DRESSING LEAKS LOW BATTERY Canister Full LED lights accompanied by an intermittent audible alarm Unit will continue to alarm until the canister is replaced Lo
12. authorized individuals from changing the therapeutic settings inadvertently Locking To lock the unit press and hold the desired therapy level 70 120 150 mmHg for three seconds until three audible beeps are heard At this point the unit is locked Pressing any other therapy level will result in three beeps with no change in setting This therapeutic setting will be recalled each time the unit is powered OFF and ON and the unit will remain locked until it is subsequently unlocked by the caregiver Unlocking To unlock the unit press and hold the selected therapy button the lit button until three audible beeps are heard At this point the unit is unlocked and therapy settings can be changed Additionally when the unit is powered OFF and ON the unit will remain unlocked and will automatically revert to the default setting of 120 mmHg SVED System User s Manual 17 Wound Care Anywhere 5 Specifications SVED Wound Treatment System Dimensions P PM 7 5 x 2 5 x 6 8 in 19 05 x 6 35 x 17 27 cm ipie 1 9 Lbs 862 gP Therapy SettingS cccccvesvesssecccseccuessecasescccccevensvivsesccseceveesexasescceeccvvaversvessdseccueesexsvesscseceveeavesveccesecede 70 120 amp 150 mmHg Canist r hl M B 300cc G US 60601 IEC60601 1 EN60601 1 and CAN CSA C22 2 No 601 1 IEC Classification Gy Medical Equipment with respect to electric shock fire and mechanical h
13. azards only in accordance with UL e Medical Equipment e Equipment not suitable for use in presence of flammable anesthetic mixture with air oxygen or nitrous oxide e Continuous Operation e Type B Applied Part e Class Il Internally Powered Equipment e PXO Battery D ration Fully Ghatee dG socvcctecwnseessvssvavedeutestessoseacevensvaessonnetavdeueerasanstacatesensnssdoenneacduenaseseseanents approximately 12 hours Electrical External Power Supply Mp Utiss nsise riie onsets vant Fi e eoa eer eda ro ee eo abra Osii SOENE 100 240 VAC 50 60Hz 700 mA External Power Supply Ro tio 15 VDC 2 Amps Patient amp Enclosure leakage Curent sis 5 ee sien eei euet rere ete verae eye ea aeree ye Ro sacl aa eie eU ra ee ree oa Cere Ede 100 Micro amps Environmental Conditions Storage Conditions Temperature Rage oiii eere ee err REEF tes svedesevossetcacsyedtec RR EH PERPE EYE EER ENERO T UE 10 F 12 C to 110 F 43 C Relative Humidity Range e eee eroe eno ree eno uana r eto anao ee auae reae usan e beau Ea apod eos SASER 20 95 Non condensing Atmospheric Pressure Rage loeo eere eter sete tete en nr ri ee eee EEO ui erae eS Eruca PENEI E eve aa EN EE Ee E aee ESEE ERE SiiS 50 kPa to 110 kPa Operating Conditions T rriperature Ratige iecit reno irr erre Eee i ve Eee PER EFE AEn S EETNL EaR EEE EYE RN KEY FEE ERA eU 40 F 4 C to 90 F 32 C Relative Humidity RANG cscs ciccvcccetevessssecesccoescuecats
14. ct the unit from the patient and power source before cleaning or servicing SVED System User s Manual 5 Wound Care Anywhere Daily Care amp Cleaning Perform a visual inspection of the unit Check for any sign of contamination and ensure that the unit is functioning properly If the unit is not operating properly refer to the Alarm Troubleshooting guide in the OPERATING INSTRUCTIONS section of this manual or contact ITI to have the unit serviced If there are visible signs of contamination or the unit ap pears dirty follow the WEEKLY CARE AND CLEANING instructions below Weekly Care amp Cleaning To help reduce the risk of infection and contact with contaminated blood and bodily fluids please wear the protective equipment identified above when cleaning the SVED Wound Treatment Unit NOTE Always follow Universal Safety Precautions Follow established institution protocols regarding clean versus sterile technique The following cleaning procedure must be performed at least once a week and must be completed between patients The SVED Wound Treatment Unit should be wiped with either a diluted solution of 5 milliliters bleach in 1 liter of warm water approximately 1 teaspoon bleach in 1 quart water or mild disinfectant Use a coarse cloth and wring out any ex cess solution until the cloth is damp and not dripping Other cleaning fluids are not recommended as they may damage the finish of the enclosure A C Adapter Inspection The A C
15. emark of Convatec The Quantum system and certain components may be subject to one or more of the following patents 7 532 953 7 608 066 8 066 243 other patents pending All Rights Reserved Worldwide P N 6702232M Rev C 1 12 Svedman and SVED are registered trademarks of Innovative Therapies Inc Innovative Therapies Inc owns uses or has applied for the following trademark s or service mark s Quantum Svedman SVED SensiSkin Speed Connect Outcomes Focused Wound Therapy and Wound Care Anywhere All other trademarks are trademarks of their respective owners or holders 2013 Innovative Therapies Inc Please refer to the Innovative Therapies product manual for indications contraindications precautions and safety information Always consult a physician and product instructions for use prior to application Caution Federal law restricts these devices to sale by or on the order of a physician 6701132M Rev C t 7 3770 Park Central Boulevard North n n OVa ive Pompano Beach Florida 33064 Call our customer support www itimedical com Therapies professionals at 1 866 484 6798 customerservice itimedical com
16. herapy see OPERATING INSTRUCTIONS Canister Removal Press the OFF button to turn the therapy off Close both tubing clamps engaged Remove tubing connector from top of canister Press canister release button and withdraw canister from bottom of unit Dispose of canister according to local state and federal regulations as well as institutional protocols Dressing Removal Carefully read the SAFETY TIPS in the INTRODUCTION section of this guide prior to removing the dressing NOTE Wounds must be carefully monitored at regular intervals In a non infected wound dressings should be changed every 48 to 72 hours but no less than 3 times per week with the frequency of dressing change determined by the clinician Infected wounds must be monitored continuously For infected wounds dressings may need to be changed more often than 48 72 hours the dressing change interval should be based on a clinical evaluation of the wound condition rather than a fixed schedule NOTE The Canister should be replaced when full the Canister Full alarm activates or at least once every week to minimize the potential for contamination and production of odors 1 2 gt Press the OFF button to turn the therapy off Close both tubing clamps engaged Disconnect SpeedConnect Suction and Irrigation tubes Twisting the tapered connector will make removing the Suction tube from the Canister easier Slowly pull drape up and away from sk
17. hest wall or non intact fascia use the lowest pressure setting on the SVED Wound Treatment Unit SPINAL CORD INJURY In the event a patient experiences autonomic hyperreflexia sudden elevation in blood pressure or heart rate in response to stimulation of the sympathetic nervoussystem discontinue use of the SVED Wound Treatment System to help mini mize sensory stimulation SVED System User s Manual 2 Wound Care Anywhere BODY CAVITY WOUNDS Underlying structures must be covered by natural tissues or synthetic materials that form a complete barrier between the underlying structures and the Svamp Dressing Svamp DRESSING USE The Svamp Dressings distributed by Innovative Therapies Inc are to be used exclusively with the SVED Wound Treatment System NOTE All dressing components of the SVED Wound Treatment System are packaged sterile The decision to use clean versus sterile aseptic technique is dependent upon wound pathophysiology and physician clinician preference All components of the SVED Wound Treatment System disposable set are latex free Be sure to comply with all other CONTRAINDICATIONS and PRECAUTIONS for the SVED Wound Treatment System Signs of possible infection may include fever tenderness redness swelling itching rash increased warmth in the wound area purulent discharge or a strong odor Nausea vomiting diarrhea headache dizziness fainting sore throat with swelling of the mucous membrane disorientatio
18. ies Inc ITI recommended daily and weekly cleaning and infection control procedures for the SVED Wound Treatment System The Caregiver should review this manual in its entirety before attempting to the use the product Carefully read the PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section be fore attempting to perform cleaning procedures on the SVED Wound Treatment Unit Protective Equipment Universal Safety Precautions should be used to minimize the risk of infection and contact with contaminated blood or bodily fluids during the dressing changes or disposal it is important to protect all exposed skin and mucous membranes The protective equipment includes Disposable gloves latex or latex free Protective eyewear to help prevent splashing of cleaning solutions and or blood or bodily fluids Protective mask to protect the nose and mouth from inadvertent fluid ingress Disposable impervious gown if splashing of blood or bodily fluids is possible Disposal After patient use all disposable components of the system should be treated as contaminated These include The Svamp Dressing drape tubing and connectors The exudate collection canister Suction and irrigation tubing connectors amp clamps Dispose of all disposable components in accordance with local state and federal regulations and institution protocols NOTE Cleaning procedures should not be performed when unit is connected to a patient Disconne
19. in while gently stretching drape NOTE If the Svamp Dressing adheres to the wound during removal refer to the SAFETY TIPS section of this manual 5 Discard disposables in accordance with applicable rules regulations and infection control protocols and always follow Universal Safety Precautions SVED System User s Manual 10 Wound Care Anywhere Disposal of Dressings Canister and Other Disposables To minimize the risk of infection and contact with contaminated blood or bodily fluids during the dressing changes or disposal it is important to protect all exposed skin and mucous membranes The protective equipment includes Disposable gloves latex or latex free Protective eyewear to help prevent splashing of cleaning solutions and or blood or bodily fluids Protective mask to protect the nose and mouth from inadvertent fluid ingress Disposable impervious gown if splashing of blood or bodily fluids is possible After patient use all disposable components of the system should be treated as contaminated These include The Svamp Dressing and drape The exudate collection canister SpeedConnect tubing connectors amp clamps Dispose of all disposable components in accordance with local state and federal regulations and institution protocols SVED System User s Manual 11 Wound Care Anywhere 4 Operating Instructions This section contains instructions for setting and adjusting functions of the SV
20. isks associated with excessive fluid loss Monitor patient status continually DO NOT USE for infants or other patients with low fluid volume nor for patients at high risk of major hemorrhage The SVED Wound Treatment System is intended for use with saline solutions in a physiologic pH range that can optionally include topical wound treatment solutions Various topical agents such as hydrogen peroxide are not intended for extended tissue contact If in doubt about the appropriateness of using a solution with the SVED Wound Treatment System contact the solution s manufac turer Donotapply solutions in conflict with the manufacturer s instructions for use During irrigation therapy the Svamp Dressing is a closed system and is NOT vented to atmosphere SVED System User s Manual 1 Wound Care Anywhere e Do not use where temperature of fluid could cause an adverse reaction such as a change in patient s core body temperature During irrigation therapy the irrigation bag should be checked periodically to ensure proper fluid delivery In addi tion when a canister fills with fluid it should be replaced immediately as irrigation fluid and wound exudate will not be removed from the dressing once the canister is full SAFETY TIPS KEEP THERAPY ON The SVED Wound Treatment System should be operated at least 22 hours out of every 24 hour period Remove the Svamp Dressing if therapy is terminated or is off for more than 2 hours
21. lity of the therapy unit on the IV pole it should be clamped no higher than two times the width of the pole base The clamp should be tightened to ensure that the therapy unit cannot slide down the pole 3 Hang irrigation bag on the I V pole at a level that is higher than the level of the wound 4 Press the ON button All LED indicators will illuminate for 1 second during the power on self test after which the ON button will steadily light green 5 Dressing should collapse indicating the presence of vacuum Once dressing integrity is verified open the Dressing Irrigation Tube and adjust drip to a rate appropriate for desired therapy 6 Carefully check dressing for vacuum or fluid leaks and repair with additional Polyurethane drape material as needed 7 7 The SVED Wound Treatment System should be operated at least 22 hours out of every 24 hour period Remove the Svamp Dressing if therapy is terminated or is off for more than 2 hours in a 24 hour period SVED System User s Manual Wound Care Anywhere Therapy Setting Adjustment CAUTION Only a physician can prescribe the proper settings and irrigation protocols for the therapy unit Failure to follow product instructions or adjusting settings and performing therapy application without the express direction and or supervision of your trained caregiver may lead to improper product performance and the potential for serious or fatal injury Negative Pressure Level Adjustment The
22. n high fever 102 F 38 8 C refractory hypotension orthostatic hypotension or erythroderma a sunburn like rash may be added signs of more serious complications of infection WARNING Do not pack the Svamp Dressings into any areas of the wound Forcing dressings in a compressed manner into any wound is contrary to approved protocols SVED System User s Manual 3 Wound Care Anywhere Features Easy to use One Touch Operation Therapy can be activated simply with the push of a single button Therapy level can be quickly changed by pressing one of three buttons 70 mmHg 120 mmHg and 150 mmHg Therapy settings can be locked by the caregiver see Therapy Selection Lock Unlock Section Lighted membrane switches clearly indicate current setting to caregiver Intermittent Mode The SVED Wound Treatment System can be set to operate intermittently 5 minute 2 minute cycle Unit maintains 25 mmHg vacuum during the off state to prevent loss of dressing seal and increase patient comfort NoiseGuard Unit is virtually silent in its normal operation increasing patient comfort and compliance PowerGuard An internal battery provides approximately 12 hours of operation from a single full charge Battery charges while unit is operating with the AC adapter While running on battery a low battery alarm will chirp and the OFF button will begin flashing when remaining capacity of the battery is less than 2096 TherapyGuard
23. ound therapy with irrigation SVED System User s Manual 8 Wound Care Anywhere Canister Installation 1 Ensure that an ITI Fluid Collection Canister is properly inserted in the receptacle located on the side of the therapy unit see Figure 4 The Canister should snap into place and lock The canister release button may need to be de pressed to permit canister insertion NOTE Always use a new canister with a new patient Therapy Unit TY Canister Release Button SpeedConnect Tube Connector Fluid Collection Canister Figure 4 canister Figure 5 2 Inspect the SpeedConnect Tube flanges to ensure that they are properly connected to the Svamp Dressing and that the connections are well sealed 3 Connect the distal end of the SpeedConnect Tube with the blue tapered connector to the Patient port of the Canister see Figure 5 Gently twist and push the connector on just enough to secure and seal it Also make sure that the clamp on the SpeedConnect Tube is open see Figure 6 Clamp Power Jack Figure 6 SVED System User s Manual 9 Wound Care Anywhere Plug the therapy unit s A C Adapter into a suitable 120 VAC 60 Hz 3 prong outlet Insert the power plug into the Power Jack on the side of the Therapy Unit see Figure 6 Verify the dressing application is correct the tubing is connected the Dressing Suction Tube clamp is open and the Dressing Irrigation Tube clamp is closed Begin t
24. rape for later use if needed Remove the drape s release liner and place over the Svamp and peri wound 10 Pat drape material down around the wound site and over the Svamp Dressing to ensure dressing is properly sealed 11 Cut two 1 cm diameter holes in the top of the drape at both ends of the dressing see Figure 1 12 Peel the backing from one of the SpeedConnect flanges and place it above one of the holes made in Step 11 Using the tips ofthe fingers press around the top of the SpeedConnect to ensure a good seal to the dressing see Figure 2 13 Repeat Step 12 for the second SpeedConnect flange see Figure 3 To Fluid Collection Canister To Fluid Collection Canister S t i F a 3 To Irrigation ITI Foam Dressing z aa ITI Semi permeable Drape Material Figure 1 Figure 2 Figure 3 14 Connect the irrigation side of the SpeedConnect tube with SafetyGuard to the wound Irrigation Set NOTE The solution to be used for wound irrigation should be appropriate for topical applications see SVED Wound Treatment System Indications and Precautions for more information on the suggested types of aqueous wound therapy solutions Make sure that the clamp on the Irrigation Tube remains closed until therapy is started 15 When irrigation is discontinued for example while changing the fluid reservoir place the Tubing Cap on the irrigation side of the SpeedConnect tube 16 Proceed to the therapy unit instructions to apply negative pressure w
25. re are three settings of negative pressure that can be selected 70 mmHg 120 mmHg and 150 mmHg The negative pressure selector buttons are located on the bottom front of the control panel Use these buttons to select the therapy setting that is appropriate for the patient 1 When the unit is powered up the default setting of 120 mmHg is automatically selected unless therapy setting has been locked previously by caregiver see Therapy Selection Lock Unlock Section 2 To change the setting simply press the desired setting button 3 The setting button will flash indicating the selection has been made and will continue flashing until the desired negative pressure level has been achieved at which time the button will stay illuminated Intermittent Mode ON OFF S W Ver 2 57 amp Higher The SVED can operate in an intermittent suction mode with a 5 minute on and 2 minute off cycle To turn the intermittent mode on press and hold the desired setting button then momentarily press the OFF 0 button The unit will beep e e and the green ON 1 button will begin flashing indicating the unit is now operating in intermittent mode Release both buttons To turn the intermittent mode off and return the device to the default continuous mode repeat the above steps The unit will produce a single long beep and the green ON 1P button will steadily illuminate The SVED will remember the mode setting when the power is turned OFF and ON
26. sseneceatinocdsgeccsvecatenecstases eveavsneaasseseseseauenetass as 20 75 Non condensing Atmospheric Pressure Ranges aie eh ext esce o eo rh erre eerie e yv ebadx tav ve eot eo suedacssscuasssiabdsssesseases arndasarsstssiaveses 50 kPa to 110 kPa Service life of SVED Wound Treatment System sseeseeeeeee eese eene nee nennen eene nnn nnse esee nennen nnss eene enn 3 years CAUTION Federal law restricts this device to sale by or on the order of a physician Specifications subject to change without notice SVED System User s Manual 18 Explanation of Symbols Device A gt ol Dressings gt STERLE R STERILE EO EREN E Refer to User Iretructions Class I Internally Powered Equipment Type B Applied Pan Refer to User Instructions Method of Sterilization Radiation Method of Sterilization Ethylene Oxides Expiry Date Date of Manufacture Loi Batch Number Storage Conditions IPXO dx AN MA Wound Care Anywhere Alternating Current Noi protected against harrrful effects af water Fragile Keen Dry Single Use Only Conforms with the Medical Device Directive S3 4S EEC and has been subject to the caniarmity procedures laid down In the council directive Wound Care Anywhere 6 Replacement Parts Description Part Number Therapy Unit Quantum Wound Treatment System eecsssssssccccceesssssssseccceceeesssssnseececee
27. sssasevax oux ES REN FEN ENUPEX ERN AN EREEE sisien 12 Power ON OFF ssssscscscssssssssssiezossscisesesssssersssssdsssssasdoesssssssoosisisi tS 12 Power Up PrOCe Uli Gs scass cacicedeceasachsashdactdudacecsssechsesvestutachetaiasasieaiees 13 Therapy Setting Adjustment sssssssssssssessessssssssssssssssssssceeeeeeeeess 14 Battery OIDCLAUION cicsud ccecsacdscacnacudasecesdcecadecdeiaseaes vasaecseecectaeeradecunece 15 Alarm ODeratloli sssascsueacesidvcdisccewsdasaascecscadecssendees caisetedesantadeeeseience 16 Therapy Selection Lock Unlock sescidessncancatacestscivicsencereiaemssinetasouss 17 5 Specifications NM DR 18 sin 19 6 Replacement Parts idoesecieeiue eitis Nerei tei ae uv viet eI EOM ANO EM VE 20 7 Questions I Information 25 paso k obedece o Fou oe sabe a vp Ven aoro eU Voi Pos ES eE 21 Wound Care Anywhere 1 Introduction Indications The SVED Wound Treatment System is indicated for patients who would benefit from vacuum assisted drainage with delivery of topical wound treatment solutions and suspensions over the wound bed Types of wounds for which the SVED Wound Treatment System has been indicated include chronic acute traumatic subacute and dehisced wounds diabetic ulcers pressure ulcers flaps and grafts Contraindications The SVED Wound Treatment System is contraindicated for patients with malignancy in the wound untreated osteomyelitis non enteric and unexplored fistulas
28. ssssssaseceeeecesssssaeeeeeseeeeseesaaeeeeeeseeens 6701132 Quantum User s Man al ri re e e EY YO E I EE CEY KY EE KR EREEECRR ERE CHEF FERRY RP EE NSARE 6701132s Power Supply AC Power Adaptet szcsecscessssssccercacvvinssvaseezetentvenssitsseduwevscnsanasssceucenvessssnseesevesncessavtseadeueeivena tabseedeneevesedanescedeternesd 47 9000 Dressings SVAMP Small Foam Dressing Set 10 per case cssccccesssscccssssscccessscecesseeecesssucecessuceceessueecesssasecesssaeeeesesaneeeeeees 47 1702 SVAMP Medium Foam Dressing Set 10 per CaS ccccsssscccssssscccesssscccseseeccessseeceessueecesssacecesesaeesesssasesesssaeeseeees 47 1701 SVAMP Large Foam Dressing Set 10 per CaSE cssscccssssscccsessscccsessecccseseeeesessueeceessueeceeesusecesssueeeeeesaseesessaseceseses 47 1700 SVAMP X Large Foam Dressing Set 10 per CaS sscccccsssscccssssscccesssecccsssseccessscecessucecesssaeecesssaeeeesesasesesseaeeeseeses 47 1703 VITIMFoam Dressing 10 DEL Cd56 ou eei eroe ren reo aa ehe reU OTENE EEE A E E E E 47 1751 Canisters Disposable Canister with Gel 300 cc 10 per case cssscccsssseccesssstcccesssecccesssscecesssuceecessseeecessaeeeceessaeeceeeueeeeeees 47 4000 Disposable Canister with Gel 1 200 cc 10 per CASE ssscccssssscccssssscccesssecccessscecesssuceeeeesseceseesaseeseesaueeseeeueeseeses 47 5000 Accessories IV Pole Bed Hanser Adapter cootra oer eere ovo tue eye hd sardo qe Ye ee EENE EE LEN ERN Eve eee a S 47 5500
29. w Pressure Leak LED lights accompanied by an intermittent audible alarm Unit will continue to alarm until the low pres sure leak condition is corrected or the alarm is cleared The OFF button will flash on and off accompa nied by an intermittent audible chirp every 10 seconds The unit will continue to alarm until connected to an A C power source When the charge falls below a critical level the therapy will be discontinued Turn unit off by pressing the OFF button Remove canister and replace as necessary Press the ON button to resume therapy If conditions persist refer unit for servicing as the internal protective filter may be blocked Check all tubing connections between the ther apy unit and Dressing Check to ensure the canister is fully seated and locked Check for cracks in the canister or lid separation Pat around drape to check for leaks If leak is found Utilizing an approved ITI A C Adapter connect unit to an A C power source to provide operat ing power and to recharge the internal battery NOTE In the event of an emergency please contact your treating physician caregiver or your local emergency responders NOTE If an Alarm Condition persists and cannot be resolved please contact ITI for further assistance SVED System Users Manual Wound Care Anywhere Therapy Selection Lock Unlock The SVED Wound Treatment Unit is equipped with a therapy locking feature designed to prevent un
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